Chain of identity and custody, designed and implemented end to end
In a therapy made for one patient, the product has to stay tied to that patient through every handover, and each identifier and label has to carry the link. Opyflow designed the chain of identity and custody, implemented it through the procedures it wrote and supported the validation.
Patient information, biological material, manufacturing records and product labels moved through different systems and teams.
Opyflow worked alongside the client's quality and IT teams. The validation itself was performed by an external validation company, with Opyflow in a supporting role.
End-to-end COI/COC process designed and implemented in SOPs Opyflow wrote · 14 integrated test cases run by an external validation company · System transactions, labels and physical handovers tested together
The challenge
Each product was made for one patient. Its identity had to stay consistent as an order became incoming material, then a manufacturing batch and laboratory samples, and finally a shipment; that continuity is the chain of identity (COI). The chain of custody (COC) had to record every movement and every transfer of responsibility. A gap between any two steps put the match between patient and product at risk.
The complexity sat at the handovers, where a record had to reach the next system with the correct identifiers and a printed label had to match the material. Someone also had to carry out the required check, record it and pass the right information on.
Opyflow's work
Opyflow walked the process step by step with the people responsible for receiving, manufacturing, quality and logistics. The resulting process map showed, for every identity check and custody event, who checked what at which step and where the evidence would be recorded.
The programme connected that process to the patient-order platform, the manufacturing system, the integration layer and the label-printing workflow. Dry runs of the handovers looked for unclear responsibilities and for places where the work as done departed from the written process. Readiness tracking gave one view of where system documentation, procedures, batch records and training stood.
In the integrated validation, simulated patient identifiers and materials went through registration, order handling, receipt, manufacturing, labelling and shipment, and the system transactions, labels and physical handovers were tested together in that sequence. Each discrepancy was captured within the validation, so the quality team had evidence of execution to review.
The issues that came up, in location identification, barcode use, sample traceability and the controls for several batches moving through the site at once, each became a defined change with an owner and a priority.
What changed
When the controls went live in the SOPs, the identity and custody checks became part of daily work at the site. For each handover the procedures set out how the patient-linked identifier is carried across, how the material is checked and who records the event, and they cover the periods when several batches are in the facility at once.
Why test the whole chain when each system is already qualified?
Qualification shows that each application works on its own. A handover also needs the system transaction, the label and the physical transfer to refer to the same patient-linked product, with a clear owner and a procedure that matches the physical activity. Application tests look at one system at a time, so issues in that sequence show up only when it is tested end to end.
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